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Намерени 282 изпитвания Стр. 13 от 15

Активно (без набиране) Фаза 3

A Randomised, Double-Masked, Placebo-Controlled Phase 3 Study on the Efficacy and Safety of STN1013800 (Oxymetazoline HCl 0.1% Eye Drops) used twice daily (BID) in the Treatment of Acquired Blepharoptosis

Acquired Blepharoptosis

Trial status: Authorised PRO: PGIC on Day 14 Change from baseline in MRD1 on Day 14

Начало: 20.11.2024 Възраст: от 18 г.

Czech Republic, France, Germany +5 Santen 2024-513356-15-00

Активно (без набиране) Фаза 2

NEOADJUVANT ATEZOLIZUMAB AND ADJUVANT ATEZOLIZUMAB + BEVACIZUMAB IN COMBINATION WITH PERCUTANEOUS RADIOFREQUENCY ABLATION OF SMALL HCC: A MULTICENTER RANDOMIZED PHASE II TRIAL

Hepatocellular carcinoma

Trial status: Authorised Recurrence-free survival: Recurrence is defined as recurrence or death, whichever comes first. Recurrence is defined as emergence of ≥ 1cm nodules enhanced at arterial phase followed by washout at portal or late phase observed on MRI, or any atypical nodule on imaging with histological features of HCC (EASL guidelines). Emergence of extrahepatic metastasis is also considered as a recurrence. Patients will be followed by MRI, 3, 6, 9, 12, 15, 18, 21and 24 months after randomization

Начало: 20.11.2024 Възраст: от 18 г.

France Centre Hospitalier Universitaire De Montpellier 2024-519113-59-00

Активно (без набиране) Фаза 3

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Povetacicept in Adults with Immunoglobulin A Nephropathy (RAINIER).

Immunoglobulin A Nephropathy

Trial status: Authorised 3. Change From Baseline in eGFR at Week 104 [Time Frame: From Baseline at Week 104]., 4. Time to Kidney Disease Progression Through Week 104 Kidney disease progression defined as greater than or equal to (≥) 30% decline in eGFR, end stage kidney disease, or non-accidental death. [Time Frame: From Baseline Through Week 104]., 1. Change from baseline in serum Gd-IgA1 at Week 36, 2. Proportion of subjects to achieve hematuria resolution at Week 36 (among subjects with hematuria at baseline) 1. Change From Baseline in 24-hour Urine Protein to Creatinine Ratio (uPCR) at Week 36 [Time Frame: From Baseline at Week 36]., 2. Total Estimated Glomerular Filtration Rate (eGFR) Slope Through Week 104 [Time Frame: From Baseline Through Week 104].

Начало: 11.11.2024 Възраст: от 18 г.

Austria, Belgium, Croatia +16 Alpine Immune Sciences Inc. 2024-514135-17-00

Активно (без набиране) Фаза 3

Renal Adjuvant MultiPle Arm Randomised Trial (RAMPART): An international investigator-led phase III multi-arm multi-stage multi-centre randomised controlled platform trial of adjuvant therapy in patients with resected primary renal cell carcinoma (RCC) at high or intermediate risk of relapse

Renal Cell Carcinoma

Trial status: Authorised Metastasis Free Survival (MFS), defined as the interval from randomisation to first evidence of metastases or death from RCC., RCC specific survival time, defined as the time from randomisation to death from RCC., Quality of life, Toxicity, Patient preferences for adjuvant immunotherapy Disease Free Survival - defined as the interval from randomisation to first evidence of local recurrence, new primary RCC, distant metastases, or death from any cause, whichever occurs first., Overall Survival - defined as all-cause mortality, the time from randomisation to death from any cause (including RCC).

Начало: 16.10.2024 Възраст: от 18 г.

France, Spain University College London 2024-513219-29-00

Активно (без набиране) Фаза 3

A multicentre, prospective, open-label, uncontrolled Phase 3 study to assess the efficacy, safety and pharmacokinetics of Atenativ in patients with congenital antithrombin deficiency undergoing surgery or delivery

Congenital antithrombin deficiency

Trial status: Authorised • PK parameters: o Area under the curve (AUCnorm(0–∞)) o Maximum plasma concentration (Cmax) o Half-life (t1/2) o Mean residence time (MRT) o Clearance (CL) o Incremental in vivo recovery (IVR; peak concentration of antithrombin observed within the first hour after infusion) o Volume of distribution at steady state (Vss) o Time to reach Maximum Plasma Concentration (Tmax), • Efficacy Parameters: o Antithrombin activity; o Coagulation parameters (activated partial thromboplastin time [aPTT], prothrombin time [PT], international normalised ratio [INR] and fibrinogen), • Safety Parameters: o Adverse events (AEs) and serious AEs (SAEs); o Length of hospital stay; o Vital signs (including systolic and diastolic blood pressure, pulse rate, body temperature, respiration rate, results of physical examination); o Standard haematological and clinical chemistry safety variables, as well as thrombogenicity markers including D-dimer, prothrombin fragment 1 + 2 (F1+2)*, and thrombin-antithrombin complex (TAT)* * if available from local laboratories Incidence of the composite of TEs and TEEs in patients with congenital antithrombin deficiency under cover of Atenativ for surgical procedures or parturition to 30 days post treatment initiation.

Начало: 10.10.2024 Възраст: от 18 г.

Austria, Czech Republic, France +5 Octapharma AG 2024-515830-34-00

Активно (без набиране) Фаза 3

ALL SCTped 2012 FORUM - Allogeneic Stem Cell Transplantation in Children and Adolescents with Acute Lymphoblastic Leukaemia

Acute Lymphoblastic Leukaemia

Trial status: Authorised Stratum 1: EFS, Stratum 2: OS, Stratum 1 and 2: Cumulative Incidence of Treatment-related mortality (TRM), Stratum 1 and 2: Cumulative Incidence of Relapse, Stratum 1 and 2: Toxicity: acute and late, Stratum 1 and 2: Acute Graft versus Host Disease (aGVHD) and chronic GVHD (cGvHD), Stratum 1 and 2: Secondary malignancies Stratum 1: Overall Survival (OS), Stratum 2: Event Free Survival (EFS)

Начало: 09.10.2024 Възраст: 18–64 г.

Austria, Belgium, Czech Republic +9 St. Anna Childrens Cancer Research Institute GmbH 2024-512657-24-00

Активно (без набиране) Фаза 2

A Phase Ib/II Study of APG-2575 as a Single Agent or in Combination with Other Therapeutic Agents in Patients with Relapsed and/or Refractory Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) (SACRED).

Relapsed and/or Refractory Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL).

Trial status: Authorised Secondary endpoints include determining the effectiveness of APG-2575 as monotherapy and in combination with other anticancer agents in patients with relapsed and/or refractory CLL by determining ORR (CR and PR) and MRD negativity. Primary endpoints include characterizing safety and tolerability, defining the MTD and recommended phase 2 dose (RP2D).

Начало: 17.09.2024 Възраст: от 18 г.

Hungary, Poland Ascentage Pharma Group Inc. 2024-515654-25-00

Активно (без набиране) Фаза 2

P2-IMU-838-PMS - Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients with Progressive Multiple Sclerosis (Calliper)

Progressive forms of Multiple Sclerosis

Trial status: Authorised Time to 24-week confirmed disability worsening as assessed on a composite of EDSS, 9-Hole Peg Test (9-HPT), or Timed 25-foot Walk (T25-FW) (24wCDW-Comp) during the MT period Annualized rate of percent brain volume change (PBVC) during MT period.

Начало: 12.09.2024 Възраст: 18–64 г.

Bulgaria, Czech Republic, Germany +3 Immunic AG 2024-514617-35-00

Активно (без набиране) Фаза 3

A phase 3, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of subcutaneous sonelokimab in adult participants with moderate to severe hidradenitis suppurativa (M1095-HS-301)

hidradenitis suppurativa (HS)

Trial status: Authorised 6. Treatment-emergent adverse event (TEAEs), 7. SAEs, 8. TEAEs leading to study withdrawal, 9. Adverse event of special interest (AESIs), 10. Physical examinations, vital signs, and ECG results, 11. Abnormal laboratory parameters (hematology, clinical chemistry, urinalysis), 1. Percentage of participants achieving HiSCR50 at Week 16., 4. Absolute change in HiSQOL score at Week 16, 5. Percentage of participants achieving a DLQI total reduction of ≥4 (minimal clinically important difference) at Week 16 among participants with a baseline DLQI ≥4 ., 2. Percentage of participants achieving IHS4-55 at Week 16., 3. Percentage of participants achieving a ≥3-unit reduction at Week 16 in the NRS for pain in PGA among participants with a baseline NRS ≥3 Percentage of participants achieving HiSCR75 score at Week 16

Начало: 02.09.2024 Възраст: от 18 г.

Austria, Bulgaria, Germany +5 MoonLake Immunotherapeutics AG 2024-511360-87-00

Активно (без набиране) Фаза 1

A Double-Blind, Randomized, Three-arm, Active-Controlled, Parallel-Group, Phase 1 Study Evaluating Pharmacokinetic Similarity of Three Formulations of Pembrolizumab (CT-P51, EU-approved Keytruda, and US-licensed Keytruda) as Adjuvant Therapy in Patients with Completely Resected Stage IIB, IIC, and III Melanoma

Completely Resected Stage IIB IIC and III Melanoma

Trial status: Authorised

Начало: 23.08.2024 Възраст: от 18 г.

Croatia, Italy, Poland +3 Celltrion Inc. 2023-510017-26-00

Активно (без набиране) Фаза 2

Hepatocellular Carcinoma on Cirrhosis With Child A/B7 and Hepatic Intra Arterial Injection of Idarubicin/Lipiodol Emulsion : Phase II, single arm, Multicentric

Hepato carcinoma cancer

Trial status: Authorised Time until treatment failure defined as the time interval between the inclusion date and the date of treatment failure. Patients alive without treatment failure will be censored on the latest news date. Treatment failure is defined as progression, the appearance of toxicities, or the inability to administer chemotherapy., Progression-free survival: defined as the time interval between the date of inclusion and the date of first progression or death (whatever the cause). Patients living without progress will be censored on the date of the last news., The rate of patients in objective response (complete response or partial response) at 6 months to from the date of the first course of chemo-lipiodol according to the mRECIST criteria evaluated according to the investigator and centralized proofreading, Tolérance defined by the NCI CTC AE v4.03 scale., Quality of life questionnaire at 12 months after the first cycle of chemo-lipiodol at baseline, and 2, 4, 6, 12 months after the first cycle, The rate of thrombosis/hepatic arterial stenosis defined as the number of courses lasting which vascular thrombosis or stenosis is/are visible on arteriography initial hepatic artery(s), divided by the total number of cures., Overall survival defined as the time interval between the date of inclusion and the date of death (all causes). Patients alive without progression will be censored on the date of latest news. Disease control rate (partial, complete or stable response) at 4 months after the first cycle of chemo-lipiodol using mRECIST criteria.

Начало: 13.08.2024 Възраст: от 18 г.

France Centre Hospitalier Universitaire De Montpellier 2024-515456-20-00

Активно (без набиране) Фаза 2

B1931036 - A prospective, randomized, open-label phase 2 study to evaluate the superiority of Inotuzumab Ozogamicin monotherapy versus ALLR3 for induction treatment of childhood high risk first relapse B-cell precursor Acute Lymphoblastic Leukaemia

Acute Lymphoblastic Leukemia (ALL)

Trial status: Authorised EFS, defined as the time from randomization until objective progression, relapse from CR/CRp/CRi, based on investigator assessment per response criteria, failure to achieve CR/CRp/CRi by the end of induction, MRD persistence prior to HSCT, second malignancy, or death due to any cause., DOR, defined as time from date of first documented response (CR/CRp/CRi) to the date of first documented objective progression, relapse from CR/CRp/CRi as determined by investigator assessment per modified NCCN response criteria, MRD persistence prior to HSCT, or death due to any cause, whichever occurs first., HSCT (and CAR T-cell therapy) rate, defined as the number and percentage of participants being transplanted and those receiving CAR Tcell therapy after treatment with InO or ALLR3., OS, defined as the time from the date of randomization to the date of death due to any cause., Incidence and severity of AEs graded per NCI CTCAE v4.03., Cmax and Ctrough Minimal residual disease (MRD)-negative, CR/CRp/CRi (per investigator assessment) at the end of induction therapy (MRD negativity is assessed by central lab and defined as leukemic blasts

Начало: 13.08.2024

Austria, Belgium, Czech Republic +13 Pfizer Inc. 2023-509810-13-00

Активно (без набиране) Фаза 2

Phase 1/2a Clinical Trial of BI-1206, a Monoclonal Antibody to CD32b (FcyRIIB), in Combination with Rituximab With or Without Acalabrutinib in Subjects with Indolent B-Cell Non-Hodgkin Lymphoma That Has Relapsed or is Refractory to Rituximab

Indolent B-Cell Non-Hodgkin Lymphoma

Trial status: Authorised Evaluation of PK parameters for BI-1206 during the BI-1206 treatment period., Evaluation of ADA response to BI 1206., Measurement of B cell depletion., Assessment of overall response rate (ORR) according to the response criteria for malignant lymphoma (Cheson, 2014). Other endpoints will include time to objective response, duration of response, PFS, and OS., CD32b protein expression levels., Expression levels of CD32b and/or other immunological markers. • Documenting AEs and SAEs (graded according to National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events CTCAE, and determining causality in relation to BI 1206, rituximab or acalabrutinib.. Causality of AEs/SAEs will be assessed by the Investigator., Phase 1: • Determining the MTD of BI-1206, with no more than 1 of up to 6 subjects at the same dose level experiencing DLT during the 28-day treatment period on induction therapy (i.e., by Day 29/Week 5). If pharmacokinetic (PK) and pharmacodynamic (PD) data suggest an optimal therapeutic dose, the escalation may be halted by the Cohort Review Committee (CRC) prior to reaching the MTD, and the RP2D will be based off the PK, PD, safety tolerability and efficacy data., Phase 2a, BI-1206 in Combination with Rituximab and Acalabrutinib: The recommended dose will be derived from totality of PK, PD, clinical response, safety, and tolerability observed.

Начало: 12.08.2024 Възраст: от 18 г.

Germany, Spain BioInvent International AB 2024-512972-36-00

Активно (без набиране) Фаза 3

A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects with Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis

Metabolic Dysfunction-Associated Steatotic Liver Disease(MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis

Trial status: Authorised 1_Change From Baseline in Liver Fat as Assessed by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF) at Week 52, 2_Percent Change from Baseline in Alanine Aminotransferase (ALT) at Week 52 and Month 36, 3_Time to First Occurrence of Disease Progression as Measured by Composite of Protocol -Specified Clinical Events Up to Month 36, 4_Absolute change from baseline in ELF score at 52 weeks 1_Proportion of participants achieving the co-primary endpoints measured at 52 weeks of: _ Improvement in fibrosis by ≥1 stage without worsening of steatohepatitis -resolution of steatohepatitis without worsening of fibrosis

Начало: 30.07.2024 Възраст: от 18 г.

Austria, Belgium, Bulgaria +7 89bio Inc. 2023-509912-27-00

Активно (без набиране) Фаза 3

Prospective, randomised, double-blind, placebo-controlled multicenter clinical trial to evaluate efficacy and safety of sublingual immunotherapy in patients with rhinitis/rhinoconjunctivitis with or without mild to moderate asthma, allergic to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae_MM09-SLG-058

Aetiological treatment of moderate to severe rhinitis/rhinoconjunctivitis with or without mild to moderate controlled allergic asthma

Trial status: Authorised Rhinitis/Rhinoconjunctivitis Symptom Score (RSS), Rhinitis/Rhinoconjunctivitis Medication Score (RMS)., Asthma and Rhinitis/Rhinoconjunctivitis Combined Symptom and Medication Score (ACSMS)., Asthma Symptom Score (ASS), Asthma Medication Score (AMS), Asthma and Rhinitis/Rhinoconjunctivitis Symptom Score (ARSS), Asthma and Rhinitis/Rhinoconjunctivitis Medication Score (ARMS), Asthma and Rhinitis/Rhinoconjunctivitis Combined Symptom and Medication Score (ARCSMS), Asthma exacerbations: Time to first exacerbation; number, duration, and severity of exacerbations, Immunological parameters in blood samples: - Total IgE - Specific IgE for D. pteronyssinus and D. farinae - Specific IgE for D. pteronyssinus and D. farinae /Total IgE ratio, Allergen profiling (ALEX technique), if serum is available, Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), Participant and investigator health status perception through a Visual Analogue Scale (VAS), Consumption of health resources., Safety parameters: - Overall rate and severity of adverse events (AE) per administration and per participant. - Evaluation of reactions at the site of administration, systemic reactions and of any medication administered for the treatment of the AE The mean of the daily Rhinitis/Rhinoconjunctivitis Combined Symptom and Medication Score (RCSMS) during the Main Evaluation Period (the last 4 week of IMP treatment) by means of the Participant’s Diary

Начало: 26.07.2024 Възраст: от 18 г.

Portugal, Spain Inmunotek S.L. 2023-505918-14-00

Активно (без набиране) Фаза 1

An early Phase 1b Study to assess how safe and effective is the treatment with drugs, called Mosunetuzumab or Glofitamab in Combination with drugs called, CC-220 and CC-99282 in Patients with B-Cell Non-Hodgkin Lymphoma.

Non-Hodgkin Lymphoma

Trial status: Authorised

Начало: 24.07.2024 Възраст: от 18 г.

Italy, Spain F. Hoffmann-La Roche AG 2023-505185-28-00

Активно (без набиране) Фаза 3

A Phase 3, Double-blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Mitapivat in Subjects With Non–Transfusion-Dependent Alpha or Beta Thalassemia (ENERGIZE)

Non–Transfusion-Dependent Alpha- or Beta-Thalassemia

Trial status: Authorised Hemoglobin (Hb) response, defined as a ≥1.0 g/dL increase in average Hb concentration from Week 12 through Week 24 compared with baseline

Начало: 23.07.2024 Възраст: от 18 г.

Bulgaria, Denmark, France +4 Agios Pharmaceuticals Inc. 2024-512745-16-00

Активно (без набиране) Фаза 2

A PHASE 2, RANDOMIZED, BLINDED, PLACEBOCONTROLLED, STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOMETRICS, AND EFFICACY OF DNTH103 IN ADULTS WITH GENERALIZED MYASTHENIA GRAVIS (MAGIC)

Generalized Myasthenia Gravis

Trial status: Authorised Efficacy: Change from baseline to Week 13 in MG-ADL scale score, Efficacy: Change from baseline to Week 13 in Quantitative Myasthenia Gravis (QMG) scale score, Efficacy: Change from baseline to Week 13 in Myasthenia Gravis Composite (MGC) scale score, Pharmacokinetics/Pharmacodynamics: Serum concentrations and PK parameters, including Cmax and Cmin, Pharmacokinetics/Pharmacodynamics: PD parameters (eg, CH50 [complement hemolysis 50%]) in serum ex vivo, Immunogenicity: Incidence and titer of antidrug antibodies against DNTH103levels against DNTH103, Safety and tolerability over 52 weeks in the OLE: Incidence of TEAEs and treatment-emergent SAEs up to Week 52 in the OLE Safety and tolerability of DNTH103 up to Week 13: Incidence of TEAEs and treatment-emergent SAEs up to Week 13 (end of the RCT period)

Начало: 22.07.2024 Възраст: от 18 г.

Czech Republic, Denmark, France +6 Dianthus Therapeutics Inc. 2024-512865-15-00

Активно (без набиране) Фаза 3

A Phase 2/3, Open-label, Baseline-controlled, Multicenter, Long-term Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Vibegron in Pediatric Subjects 2 Years to < 18 Years of Age with Neurogenic Detrusor Overactivity (NDO) on Clean Intermittent Catheterization (CIC)

Neurogenic Detrusor Overactivity (NDO)

Trial status: Authorised Secondary Efficacy Endpoints: Based on Urodynamics: - Change from baseline at Study Week 20 (Optimized Treatment Week 12) in MCC - Change from baseline at Study Weeks 20 and 32 (Optimized Treatment Week 12 and 24) in: Number of overactive detrusor contractions until end of filling; Detrusor pressure at end of filling; Filling volume until first involuntary/hyperactive detrusor contraction; Bladder compliance, Secondary Efficacy Endpoints: Based on Bladder Diary: - Change from baseline at Study Weeks 1, 4, 8, 20, 32, 48, and 52 in: average first morning catheterized volume; Average catheterized volume per catheterization; average maximum catheterized volume per day; Average maximum catheterized daytime volume; Average number of leakage episodes per day; Estimated number of dry days/7 days, Secondary Efficacy Endpoints: Based on Questionnaires: - Change from baseline at Study Weeks 20, 32, and 52 in PIN-Q - Change from baseline at Study Weeks 20, 32, and 52 in PGI-S Scale - CGI-C Scale assessment at Study Weeks 20, 32, and 52., Safety and Tolerability: - Incidence of AEs - Incidence of AESIs - Upper urinary tract ultrasound assessment - eGFR - Vital signs measured at clinic visits: pulse rate, systolic and diastolic blood pressure - 12-lead ECG, centrally read, Pharmacokinetics: - PK of vibegron in plasma: Cmax, tmax, AUC(0-24h), Ctrough, t1/2, and CL/F Change from baseline at Study Week 32 (Optimized Treatment Week 24) in MCC based on filling urodynamics

Начало: 22.07.2024

Belgium, Croatia, Denmark +6 Sumitomo Pharma America Inc. 2024-513995-16-00

Активно (без набиране) Фаза 1

A Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of Furmonertinib in Patients with Non-Small Cell Lung Cancer with Activating EGFR or HER2 Mutations (FURTHER)

Non-Small Cell Lung Cancer (NSCLC) harboring activating EGFR or HER2 kinase domain mutations

Trial status: Authorised

Начало: 11.07.2024 Възраст: от 18 г.

France, Italy, Netherlands +1 Arrivent Biopharma Inc. 2023-508349-42-00

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